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Tissue Data Specialist

Job Title
Tissue Data Specialist
Job ID
27603266
Work From Home
Yes
Location
Remote, 
Other Location
Hudson, FL
Description

About M2GEN

M2GEN is an oncology-focused health informatics solutions company that leverages clinical and molecular data to accelerate the discovery, development, and delivery of personalized therapies.  Founded in 2006 with a mission to enable a collaborative approach to fight cancer, M2GEN facilitates the Oncology Research Information Exchange Network (ORIEN), an alliance of leading cancer centers that participate in the HIPAA-compliant, IRB-approved protocol, patient-consented Total Cancer Care (TCC) to gather de-identified clinical and genomic patient data for research purposes.  M2GEN currently has over 300,000 total consented patients across a network of 18 cancer centers throughout the U.S. 

We are a fast growing company, merging data and science to accelerate the discovery and delivery of precision medicine.  Our purpose is to connect patients to a cure so they can lead better lives.  If you are passionate about making a difference and creating and delivering health informatics solutions to impact the future of cancer care and predicting and meeting patient’s needs, join the team!

Learn more at www.m2gen.com

Role

M2Gen is looking for a hands-on tissue data specialist with extensive knowledge of biospecimen processing activities, along with the associated data needs. You will be responsible for the operational and system integration across all aspects of biospecimen requests, submission, and annotation. Bringing a compliant data capture and continuous quality improvement mindset will be necessary for M2Gen’s success in developing a leading-edge tissue data capture pipeline that can empower advanced analytics/machine learning and data science/reporting capabilities.

Responsibilities (this is not an all-inclusive list, duties may evolve over time as business needs change)

  • Work closely with the Senior Director of Clinical Integration & Informatics, Data Acquisition team, Clinical Integration team, Sales team, ORIEN team, and outside providers to implement and document biospecimen processing and annotation appropriate to project and product parameters. This includes, but is not limited to:
    1. Subject matter expert in biospecimen tracking and annotation
    2. Creation and maintenance of policies and procedures related to biospecimen processes
    3. Development, testing, and implementation of an M2GEN LIMS system
    4. Point of contact for biospecimen orders and project annotation as appropriate
    5. Tissue data quality lead
  • Function as part of a multidisciplinary team in support of the overall operational support plan
  • Liaison with various members of the client and provider groups for tissue related activities
  • Represent M2GEN on various ORIEN committees and working groups as required

Education / Experience

  • Bachelor’s Degree or higher in Biology, Public Health, or related science field.
  • 5+ years in research or clinical laboratory services, preferably in pathology/oncology specifically.
  • 3+ years specimen processing, handling, and shipment of surgical, cytological, and fluids/derivatives.
  • 2+ years hands-on experience in reporting, project development, and project management within a LIMS system
  • Clinical laboratory (MT, MLT, HTL) or ISBER biorepository certification a definite plus.
  • IATA certification will need to be attained

Knowledge / Skills / Abilities

  • Proven ability to communicate and collaborate with business, clinical, technical, and non-technical team members and the ability to understand and adapt to changing customer needs in highly competitive conditions.
  • Knowledge of compliance and regulatory environments related to biospecimen processing and annotation. These include, but are not limited to, GLP, GCP, CAP, CLIA, and IATA. Specific knowledge in managing PHI and HIPAA in research and clinical practice a plus.
  • Knowledge of oncology drug development process from basic research to post marketing surveillance a plus
  • Deep understanding of specimen collection, processing, and annotation and the representation of these steps within a reporting system a must
  • Proficient with MS Office Suite – Word, Excel, PowerPoint, Outlook.
  • Hands-on experience with various EHR, CTMS, EDC, and LIMS software, tools, systems.

Our Values

Put Patients First– because they inspire us

Be Bold – be proud but not satisfied, be trailblazers

Create Knowledge – transform data into wisdom through shared information and team science

Lead by Example – Support and encourage others to work and grow in a way that brings out their best

Join the Conversation – Collaborate openly and honestly. Build community and relationships that last

 

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